Abstract

Cladribine Tablets (MAVENCLAD®) received its marketing authorization from the European Medicines Agency (EMA) for the treatment of persons with Highly Active Relapsing Multiple Sclerosis (HA-RMS) in 2017. Since then, in the United Kingdom (U.K.), it was assessed by the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium, where it has received positive approval for use in the National Health Service (NHS). The aim of this analysis was to assess the budget impact of Cladribine Tablets against other HA-RMS Disease Modifying Treatments (DMTs), such as alemtuzumab, fingolimod, and natalizumab in a UK setting A budget impact model with a 5year time horizon, was developed with a U.K. NHS perspective. The comparators included were; alemtuzumab, fingolimod, and natalizumab. Administration and monitoring costs were obtained from the NHS reference tariffs 2016/17. The acquisition costs were sourced from the British National Formulary (BNF) published prices. Adverse Event (AE) costs were not included in this analysis. Epidemiology of multiple sclerosis (MS) was from Jick et al (2015). Market shares were based on previous NICE costing templates. A 2.5% annual uptake assumption of Cladribine Tablets was used, which was dispersed evenly amongst comparators. Over a 5-year period, this analysis estimated that 20,729 HA-RMS patients would be eligible for a DMT. Of these, if 2,149 persons were considered treated with Cladribine Tablets it would result in a net budget change of £-7,516,705. This is a saving of 1.9% to the NHS budget. In this analysis Cladribine tablets had less acquisition, monitoring, and administration costs per patient. Due to this unique posology and lower administration and monitoring requirements, Cladribine Tablets is estimated to provide budget savings to the NHS when compared with alemtuzumab, fingolimod, and natalizumab.

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